A Randomized Trial Of PF-00299804 Taken Orally Versus Erlotinib Taken Orally For Treatment Of Advanced Non-Small Cell Lung Cancer That Has Progressed After One Or Two Prior Chemotherapy Regimen
- Registration Number
- NCT00769067
- Lead Sponsor
- Pfizer
- Brief Summary
This study will compare PF-00299804 given orally on continuous schedule to the approved drug, erlotinib, in patients whose non-small cell lung cancer has progressed after chemotherapy; patients will be randomized to receive one of these drugs, and followed for efficacy and tolerance of each.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 188
- advanced measurable Non-Small Cell Lung Cancer (NSCLC);
- progressed after 1-2 prior chemotherapy;
- Eastern Cooperative Oncology Group (ECOG) 0-2;
- tissue available for future KRAS/ EGFR testing
- prior Epidermal Growth Factor Receptor (EGFR) targeted therapy;
- active or untreated Central Nervous System (CNS) metastases;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A Erlotinib - B PF-00299804 -
- Primary Outcome Measures
Name Time Method Progression-Free Survival (PFS) Baseline until disease progression or death, assessed at Cycle 2, 3, 4, 5, 6, thereafter every other cycle up to end of treatment (121 weeks), followed by every 8 weeks >284 weeks PFS: Time in weeks from randomization to date of objective disease progression or death due to any cause, whichever occurred first. PFS was calculated as (first event date or last known event-free date \[if the event date unavailable\] minus the date of randomization plus 1) divided by 7. Objective progression is defined using Response Evaluation Criteria in Solid Tumors (RECIST), as at least 20 percent (%) increase in the sum of longest dimensions (LDs) of target lesions, taking as reference the smallest sum of LD recorded since the treatment started and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Objective Response Baseline until disease progression or death, assessed at Cycle 2, 3, 4, 5, 6, thereafter every other cycle up to end of treatment (121 weeks), followed by every 8 weeks >284 weeks Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST version 1.0. CR: disappearance of all target and non-target lesions. PR: at least 30 % decrease in sum of the LDs of target lesion, taking as reference the baseline sum LD. Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response.
Categorical Summary of Overall Scale Change in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Baseline up to Cycle 44 (Week 188) EORTC QLQ-C30: included global health status/quality of life (QoL), functional (Fn) scales (physical, role, cognitive, emotional, and social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, and financial difficulties). Scores were averaged, transformed to 0-100 scale; higher score for Global Qol/Fn scales=better level of QoL/functioning or higher score for symptom scales/items=greater degree of symptoms. Overall scale change is categorized as Improved (if average scales change from baseline: for Global QoL/Fn scales \>=10; for symptom scale/item \<=-10), Worsened (if average scales change from baseline: for Global QoL/Fn scales \<=-10; for symptom scale/item \>=10), and Stable (if average scales change from baseline \>-10 but \<10 for Global QoL/Fn scales and symptom scale/item) and participants in each category are reported.
Overall Survival (OS) Baseline until end of treatment (15 August 2014); followed up every 8 weeks after discontinuation from study treatment. Time in weeks from randomization to date of death due to any cause. OS was calculated as (the death date or last known alive date (if death date unavailable) minus the date of randomization plus 1) divided by 7.
Duration of Response (DR) Baseline until disease progression or death, assessed at Cycle 2, 3, 4, 5, 6, thereafter every other cycle up to end of treatment (121 weeks), followed by every 8 weeks >284 weeks Time in weeks from first documentation of objective tumor response to objective tumor progression or symptomatic deterioration or death due to any cause, whichever occurred first. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or symptomatic deterioration or death due to any cause or last known progression-free date \[if none of the event dates available\] minus the date of the first CR or PR \[which ever occurred first\] that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of participants with a confirmed objective tumor response.
Dermatology Life Quality Index (DLQI) Cycle (C) 1 Day (D) 1 (baseline), C1D10-14, D1 of subsequent cycles up to C44 DLQI: 10-item questionnaire to measure how much the participant's skin problem has impacted their life over the previous week on following 6 domains: symptoms/feelings (2 questions), daily activities (2 questions), leisure (2 questions), work/school (1 question), personal relationships (2 questions), and treatment (1 question). All questions were answered on a 4-point Likert scale ranging from 0 (not at all/not relevant) to 3 (very much/prevented work or studying). The DLQI total evaluable score was calculated by summing the score of each question and ranged from 0 to 30, where higher scores indicated more quality of life impairment.
Best Overall Response (BOR) Baseline until disease progression or death, assessed at Cycle 2, 3, 4, 5, 6, thereafter every other cycle up to end of treatment (121 weeks), followed by every 8 weeks >284 weeks Number of participants with BOR according to RECIST version 1.0: CR= disappearance of all target and non-target lesions. PR= at least 30% decrease in sum of LDs of target lesion, taking as reference baseline sum LD. Stable/no response= neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of LDs since treatment started. Objective progression= at least a 20% increase in sum of LDs of target lesions, taking as reference the smallest sum of LDs recorded since treatment started and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.
Categorical Summary of Overall Scale Change in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) Baseline up to Cycle 44 (Week 188) QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, other pain, and medicine for pain). Scores averaged, transformed to 0-100 scale; higher symptom score = greater degree of symptoms. Overall scale change is categorized as Improved (if average scales change from baseline \<=-10), Worsened (if average scales change from baseline \>=10), and Stable (if average scales change from baseline \>-10 but \<10) and participants in each category are reported.
Trial Locations
- Locations (57)
Medex spolka cywilna
🇵🇱Chrzanow, Poland
Hospital de Cruces
🇪🇸Barakaldo, Vizcaya, Spain
"Vesalius" Sp. z o.o.
🇵🇱Krakow, Poland
Hospital Teresa Herrera
🇪🇸La Coruña, Spain
Christie Hospital NHS Foundation Trust
🇬🇧Manchester, United Kingdom
Churchill Hospital
🇬🇧Oxford, United Kingdom
The West Clinic
🇺🇸Memphis, Tennessee, United States
Irmandade da Santa Casa de Misericordia de Porto Alegre (ISCMPA) - Hospital Santa Rita
🇧🇷Porto Alegre, RS, Brazil
Hospital Sao Lucas da PUCRS
🇧🇷Porto Alegre, RS, Brazil
Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira - ICESP
🇧🇷Sao Paulo, SP, Brazil
Center for Blood and Cancer Disorders
🇺🇸Bethesda, Maryland, United States
Central Georgia Cancer Care, P.C.
🇺🇸Warner Robins, Georgia, United States
The Longstreet Cancer Center
🇺🇸Gainesville, Georgia, United States
FUNDACAO PIO XII Hospital de Cancer de Barretos
🇧🇷Barretos, SP, Brazil
BC Cancer Agency - Vancouver Centre
🇨🇦Vancouver, British Columbia, Canada
Northwest Alabama Cancer Center
🇺🇸Muscle Shoals, Alabama, United States
Agajanian Institute of Oncology and Hematology
🇺🇸Montebello, California, United States
Winship Cancer Institute at Grady Health Systems
🇺🇸Atlanta, Georgia, United States
Winship Cancer Institute, Emory University
🇺🇸Atlanta, Georgia, United States
Winship Cancer Institute at Emory University
🇺🇸Atlanta, Georgia, United States
Winship Cancer Institute of Emory University
🇺🇸Atlanta, Georgia, United States
Augusta Oncology Associates, P.C.
🇺🇸Augusta, Georgia, United States
Oncology/Hematology Associates
🇺🇸Clarksburg, West Virginia, United States
Chris O'Brien Lifehouse
🇦🇺Camperdown, New South Wales, Australia
St. Vincent's Hospital
🇦🇺Fitzroy, Victoria, Australia
RSM Durham Regional Cancer Centre - Lakeridge Health Oshawa
🇨🇦Oshawa, Ontario, Canada
John B. Amos Cancer Center
🇺🇸Columbus, Georgia, United States
Augusta Oncology Associates, PC
🇺🇸Augusta, Georgia, United States
Northwest Georgia Oncology Center
🇺🇸Marietta, Georgia, United States
Associates in Oncology/Hematology, PC
🇺🇸Rockville, Maryland, United States
Royal Victoria Hospital
🇨🇦Barrie, Ontario, Canada
The Ottawa Hospital Cancer Centre
🇨🇦Ottawa, Ontario, Canada
Zaklad Rentgena i USG Wyrobek spolka jawna
🇵🇱Krakow, Poland
¿KardioDent¿
🇵🇱Krakow, Poland
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Bridgeport Hospital
🇺🇸Bridgeport, Connecticut, United States
Ponce School of Medicine / CAIMED Center
🇵🇷Ponce, Puerto Rico
Kootenai Cancer Center at Post Falls
🇺🇸Post Falls, Idaho, United States
Medical Oncology & Hematology, P.C.
🇺🇸Waterbury, Connecticut, United States
Border Medical Oncology
🇦🇺Wodonga, Victoria, Australia
Kootenai Cancer Center
🇺🇸Post Falls, Idaho, United States
The Andrew Love Cancer Centre,
🇦🇺Geelong, Victoria, Australia
Wittingham Cancer Center @ Norwalk Hospital
🇺🇸Norwalk, Connecticut, United States
Hospital Universitari Germans Trias I Pujol
🇪🇸Badalona, Barcelona, Spain
Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie
🇵🇱Warsaw, Poland
Niepubliczny Zaklad Opieki Zdrowotnej AVI Centrum Medyczne
🇵🇱Warszawa, Poland
Taipei Veterans General Hospital, Chest Department
🇨🇳Taipei, Taiwan
National Cancer Centre
🇸🇬Singapore, Singapore
Hospital Son Llatzer
🇪🇸Palma de Mallorca, Islas Baleares, Spain
University of Minnesota Cancer Center
🇺🇸Minneapolis, Minnesota, United States
Midwestern Regional Medical Center
🇺🇸Zion, Illinois, United States
Severance Hospital, Yonsei University College of Medicine, Yonsei Cancer Center
🇰🇷Seoul, Korea, Republic of
Georgia Cancer Specialists
🇺🇸Decatur, Georgia, United States
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
SamsungMedicalCenter,SungkyunkwanUnivSchoolofMedicine,Div. of Hematology-Oncology, Dep. of Medicine
🇰🇷Seoul, Korea, Republic of
Department of Clinical Oncology
🇭🇰Shatin, New Territories, Hong Kong
Department of Clinical Oncology, Tuen Mun Hospital
🇭🇰Tuen Mun, New Territories, Hong Kong